ASP Global Recalls MPR Tourniquet Cuffs Due to Incorrect Expiration Dates
ASP Global is recalling 360 MPR single-use tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding shelf life, which is a moderate risk.
Plain-English summary
ASP Global, LLC. is recalling 360 units of MPR Single Use Tourniquet Cuffs, model number DT-7044-02Q. The recall is due to incorrect expiration dates on products manufactured between September 2016 and March 2023. The products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.
The affected lots are S0823STY, R1201STY, N0330STY, N0530STY, M0730STY, and M0930STY. The UDI-DI is 00840001403253. These sterile disposable tourniquet cuffs are intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.
The products were distributed nationwide in the United States, specifically in the states of MO, NV, IN, MN, GA, WI, PA, TX, CT, LA, NJ, FL, AL, NY, SC, NE, NC, OH, AZ, CO, MA, IL, KY, CA, VA, ME, KS, MD, TN, MS, AR, WA, NM, MI, and WY. Healthcare facilities and consumers should check their inventory for these specific lot numbers and model numbers and stop using the affected products.
The recalled product
- Product
- Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog Number: DT-7044-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally…
- Manufacturer
- ASP Global, LLC.
- Affected units
- 360
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- R1201STY
- N0330STY
- N0530STY
- M0730STY
- M0930STY
Distribution
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